1050 Participants Needed

ABX464 Maintenance Therapy for Ulcerative Colitis

Recruiting at 591 trial locations
PG
LD
CR
Overseen ByChris Rabbat
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Abivax S.A.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that certain medications and procedures for ulcerative colitis are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.

How does the drug ABX464 differ from other drugs for ulcerative colitis?

ABX464 is unique because it is being studied as a maintenance therapy specifically for ulcerative colitis, which means it could help keep the disease in remission over the long term. Unlike some existing treatments that focus on reducing immune system activity, ABX464 may offer a novel approach, potentially improving adherence and reducing the need for corticosteroids.12345

Research Team

SV

Severine Vermeire, MD, PhD

Principal Investigator

UZ Leuven, Belgium

BS

Bruce Sands, MD, PhD

Principal Investigator

Mount Sinai Health System Digestive Disease Institute, New York USA

Eligibility Criteria

This trial is for people with moderate to severe ulcerative colitis who didn't get better with standard or advanced treatments. They must have finished a previous ABX464 study and can't be planning pregnancy soon. Participants need valid endoscopy results, agree to use effective contraception, sign consent forms, and commit to the study schedule.

Inclusion Criteria

Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.
Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
I have had an endoscopy with results read by a central reader.
See 3 more

Exclusion Criteria

I plan to try for a baby in the next year.
Subjects who plan to participate in other investigational studies during the maintenance study.
Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maintenance Treatment

Participants receive ABX464 25 mg or 50 mg or placebo once daily for 44 weeks

44 weeks

Long Term Extension

Participants can continue their allocated treatment for up to 4 years after the maintenance phase

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
End of Study (EOS) visit

Treatment Details

Interventions

  • ABX464
Trial OverviewThe trial tests long-term effects of two doses of ABX464 (50mg or 25mg) as daily maintenance therapy compared to a placebo. It's randomized: some get the real drug without knowing if it's high or low dose; others get a fake pill. The treatment lasts 44 weeks followed by an evaluation after another 28 days.
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Long Term ExtensionExperimental Treatment1 Intervention
At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.
Group II: ABX464 50mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group III: ABX464 25mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group IV: ABX464 50mg - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Group V: ABX464 25mg - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Group VI: Placebo - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abivax S.A.

Lead Sponsor

Trials
22
Recruited
4,400+

Findings from Research

Maintenance therapy for ulcerative colitis (UC) is crucial for preventing relapses and improving quality of life, with current treatments also helping to reduce the need for corticosteroids and elective colectomy.
The review highlights that the use of immunosuppressive therapies is decreasing the necessity for colectomy in UC patients, indicating a shift towards more effective long-term management strategies.
Current and emerging maintenance therapies for ulcerative colitis.O'Connor, A., Moss, AC.[2016]
In a study involving 174 patients with ulcerative colitis, MMX mesalazine at a dose of 2.4 g/day showed a good safety profile, with most adverse events being mild or moderate, and only 3.9% experiencing serious adverse events.
Both once-daily and twice-daily dosing of MMX mesalazine resulted in high rates of clinical and endoscopic remission after 12 months, with 64.4% and 68.5% of patients in remission, respectively, indicating that once-daily dosing is effective and convenient for maintenance therapy.
Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis.Kamm, MA., Lichtenstein, GR., Sandborn, WJ., et al.[2022]
5-ASA is the primary treatment for mild to moderate ulcerative colitis, effectively inducing and maintaining remission by reducing local immune activity.
For severe flares, corticosteroids are preferred, but to avoid long-term use, biologics with varying safety profiles are available, aiming not just for clinical remission but also for endoscopic and histological remission to enhance quality of life and reduce cancer risk.
[Overview and update on treatment in ulcerative colitis].Rossier, L., Matter, C.[2023]

References

Current and emerging maintenance therapies for ulcerative colitis. [2016]
Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. [2022]
[Overview and update on treatment in ulcerative colitis]. [2023]
New keys to maintenance treatment in ulcerative colitis. [2021]
[Management of diagnosis and treatment in ulcerative colitis]. [2016]